The use of nutritional supplements to supplement the nutritional needs of humans is known. It is recognized that the vitamins, minerals and other substances found in such supplements play important physiological roles, and that a deficiency of certain vitamins, minerals and/or other substances has been linked to the etiology of certain diseases. Conversely, the presence of certain of these substances is known to enhance a variety of physiological states, under various conditions. It is particularly known, as well, that certain sub-groups of individuals, i.e., children, women, older adults, persons engaging in strenuous physical exercise, have specific nutritional needs not necessarily corresponding to those of the general adult population, or to each other.
The nutritional and health needs of women are known to differ in many respects from those of men. The health conditions which may develop during a woman's life include coronary heart disease, certain cancers, cervical dysplasia, menopause, and pre-menstrual syndrome. Menopausal symptoms in women can manifest themselves with varying degrees of severity. Perimenopausal women are susceptible to hot flashes. Postmenopausal women are particularly susceptible to osteoporosis.
The nutritional needs of older adults also are known to differ from those of younger adults (i.e., fifty years of age and under) in several respects. Aging is generally associated with impaired immune responses.
In addition, the nutritional and health needs of children are known to differ in many respects from those of adults. It is recognized, as well, that dietary imbalance causes physiological disorders in children, including, but not limited to, hyperactivity, hyperkinesis, and learning disabilities. It is known, for example, that hyperactivity and certain learning disorders can be treated by orthomolecular therapy, which involves regulating the concentration of particular substances (vitamins, minerals, trace elements, hormones, amino acids, enzymes) normally present in the human body.
Bodybuilders and persons engaged in strenuous physical exercise also have particular nutritional requirements, whether to decrease body fat, increase lean muscle mass, improve glucose metabolism, or merely to promote rapid recovery following aerobic and/or anaerobic exercise.
The edible dietary B and B-complex vitamins perform several well-known functions. Vitamin B1, thiamin, helps maintain smooth muscle and helps in the formation of blood cells. It is necessary, also, for proper nervous system function. Vitamin B2, riboflavin, is necessary for healthy hair, nails and mucous membranes. It also plays an important role in the formation of red blood cells and the production of antibodies. Vitamin B3, niacin, helps in the production of most sex hormones, and also helps to lower cholesterol and maintain blood circulation. Vitamin B6, pyridoxine, is involved in the synthesis of RNA and DNA, and helps relieve water retention in women. Folic acid is essential to the production of red blood cells and hormones, and is involved, as well, in DNA synthesis. Vitamin B12, cyanocobalamin, is necessary for overall metabolism and nervous system function, and is essential for the metabolism of folic acid. It also is necessary to prevent anemia. Biotin is necessary for the metabolism of proteins, carbohydrates and fats, as well as for healthy hair and skin. Vitamin B5, pantothenic acid, is important for the production of adrenal gland hormones. It is referred to as the “anti-stress vitamin.” Choline is necessary for nervous system and brain function, and is important in gall bladder and liver function. Inositol helps remove fats from arteries and from the liver, and has been noted to be necessary for brain function. Inzitol®, which is a form of D-pinitol for use in dietary supplements and manufactured by Humanetics Corporation, of St. Louis Park, Minn., supports glucose metabolism by acting as a mediator of insulin action, promoting insulin sensitivity. Para-amino benzoic acid (“PABA”) aids in the metabolism of proteins and in the production of red blood cells.
Other edible dietary vitamins exhibit other functions. Vitamin C has antioxidant properties. It is necessary for collagen synthesis, and has been shown to reduce the risk of heart disease, as well as reducing cervical epithelial abnormalities. Vitamin A prevents night blindness and other disorders, reduces the risk of lung cancer, and negates the effects of sun damage. It also possesses antioxidant properties. Vitamin D assists in the mineralization and calcification of bone, prevents osteomalacia in adults, and lowers the blood pressure. Vitamin E, along with exhibiting antioxidant properties, helps reduce the risk of lung cancer and heart disease. It also has been linked to the relief of “hot flashes” and mastodynia. Folic acid is essential to the production of red blood cells and hormones, and also aids in the formation and function of white blood cells. It also serves as a coenzyme in DNA and RNA synthesis, and thus is essential to healthy cell division and replication.
Edible amino acids and their analogs and derivatives also present physiological effects. Alanine is required for the metabolism of glucose and tryptophan. Arginine ketoisocaproate (AKIC) prevents muscle breakdown, supports brain activity, and assists in intestine repair. Asparagine is used to help maintain equilibrium. It also is required for amino acid transformation in the liver. Ornithine alpha ketoglutarate (OKG) has been shown to improve protein retention, wound repair and immune function. OKG also improves performance in hypercatabolic states associated with such activities as vigorous sports and weightlifting. Leucine assists with regulation of blood glucose levels and the growth and repair of muscle tissue. Isoleucine promotes muscle recovery after physical exercise, and is required for the formation of hemoglobin. Phosphatidylserine (PS) has applications relating to stress damage, seasonal depression, exercise recovery, immune stimulation, and memory loss. It has been shown to decrease cortisol levels, and improve mental acuity. Valine is needed for muscle metabolism, repair and growth of tissue, and maintaining nitrogen balance. Tyrosine stimulates the release of growth hormone, which causes muscle growth and reduced body fat. Glutamine helps brain function as it quickly converts to glucose. A growth hormone releaser, it improves exercise endurance. Phenylalanine is used to produce norepinephrine, and functions as an antidepressant and memory boost. Glutamine peptide, an enzymatically altered protein, has been shown to strengthen muscles. It is recommended for improved immune systems response and glycogen replenishment, particularly after exercise. 4-hydroxyisoleucine, extracted from fenugreek seed, accelerates the storage of creatine. Taurine, found naturally in breast milk, plays a significant role in brain and retinal development, as well as retinal function. Phosphatidylcholine (PC, or lecithin), taken prior to activity, prevents the decline of choline levels and improves performance. Covalently-bound zinc/magnesium aspartate (ZMA) enhances muscle strength, and is used in strength training programs. S-adenosyl-methionine (SAM-e) is a cofactor for methylation, and assists in hormone regulation and cell membrane synthesis. SAM-e also contributes to the synthesis of glutathione, essential for proper liver function. Pyroglutamic acid is associated with acetylcholine activity, and the production of the neurotransmitters GABA and glycine. Beta-hydroxy-beta-methylbutyrate (HMB), derived from leucine, is used as a supplement by bodybuilders and others trying to increase lean muscle mass.
Edible nutritional proteins and their derivatives provide specific benefits. Whey protein isolate (WPI) and milk protein isolate (MPI) have been shown effective with bodybuilders in rapidly gaining lean muscle mass while reducing body fat. WPI also has been shown to provide a smooth and pleasant mouth feel, in contrast to, e.g., soy protein isolate. WPI is high in branched-chain amino acids. MPI is primarily casein, shown effective in promoting muscle growth. Egg protein (albumen) also is high in amino acid content. Whey protein hydrosylate (WPH) has been linked to improved nitrogen retention and growth in rats. Soy protein isolate has been shown to minimize thyroid suppression, and thus is beneficial in a fat-loss program.
The nutritional physiologic effects of various edible plant extracts also are well-known. Beta carotene converts into Vitamin A for use as needed. It boosts the immune system by absorbing free radicals. It also helps reduce the risk of stroke, heart disease and many yeast infections. Caffeine has been used to treat migraine headaches and relieve (short-term) fatigue. It also increases the ability of the body to burn fat by helping liberate fatty acids from fat stores. Colosolic acid stabilizes blood glucose levels. Choline metabolizes fats and is used to treat, inter alia, arteriosclerosis and forgetfulness. Hydroxycitrate (HCA) inhibits lipogenesis, and is a well-established “fat burning” agent.
Yohimbine, from the Yohimbe tree, is used to treat impotence and a lack of libido, as well as Parkinson's disease. Mucuna pruriens, also known as velvet bean or cowitch, is efficacious in the management of Parkinson's disease by virtue of its L-Dopa content. It is recognized as an aphrodisiac, and has been shown to improve mental alertness and coordination. Dong quai, considered the ultimate, all-purpose woman's tonic herb, is used to treat almost every gynecological complaint. It is useful by men and women as a blood tonic, and contains vitamins A, E and B12. Cranberry extract helps maintain urinary tract health, and promotes cardiovascular and cellular health. Evening primrose oil is a rich source of omega-6 oils, used in the synthesis of prostaglandins. Evening primrose oil also is rich in gamma-linolenic acid (GLA), which has been shown to inhibit platelet aggregation and reduce blood pressure. Black cohosh, Cimicifuga racemosa, is used in the treatment of menopause, selectively and significantly reducing levels of luteinizing hormone.
Several edible dietary minerals have also exhibited beneficial effects. Calcium builds bones and teeth, and is necessary for proper cardiac rhythms and for the conduction of nerve impulses. Iodine helps to metabolize fats, and is necessary for proper thyroid function. It also reduces fibrocystic breast conditions. Magnesium is involved in several enzymatic reactions in the body, and has been found beneficial in the treatment of cardiac arrhythmias and the management of diabetes. Increased intake of magnesium may aid in the prevention of osteoporosis. Magnesium also helps prevent bone loss and is used, as well, in managing diabetes. Selenium possesses antioxidant properties, and has been shown to reduce the risk of heart attack and heart disease. Manganese is involved in protein synthesis and central nervous system function, assists in bone growth, and helps prevent osteoporosis. It also regulates the production and release of insulin, assists in the metabolism of fats and proteins, and assists in the production of milk, as well as the thyroid hormone thyroxin. Chromium deficiency has been linked to weight loss and glucose intolerance, as well as to peripheral neuropathy. Chromium also helps lower LDL (low density lipoprotein) and raise HDL (high density lipoprotein) levels, and may protect against coronary artery disease. Molybdenum plays a biochemical role in enzyme function. It also helps metabolize fats, and plays a role in iron utilization. Boron is used to maintain healthy bones, and allows for increased absorption of calcium, magnesium and phosphorus. Potassium is necessary for proper fluid balance, as well as proper heartbeat and nerve transmission. Zinc is needed for proper formation of RNA and DNA, and also is necessary for growth and sexual development, especially in women. Administration of moderate amounts of zinc in persons over seventy years of age has been associated with improved delayed hypersensitivity and an increase in the number of circulating T cells. Copper is necessary for collagen synthesis, and for the maintenance of collagen structures. Copper is also essential for proper functioning of Vitamin C.
In addition to the foregoing, other edible substances, including other edible plant extracts, have been shown to exhibit beneficial physiological effects. Bioflavonoids reduce capillary fragility and protect biologically-important compounds through antioxidant activity. Bioflavonoids also exhibit anti-allergy properties. The bioflavonoid hesperidin is known to improve capillary permeability, and has been used in the treatment of neuropathies; while the bioflavonoid rutin is linked to strengthening of the capillaries and anti-inflammatory effects.
The carotenoid lycopene may reduce the risk of prostate and breast cancer. It has been inversely associated with the risk of cervical cancer in women. Also, the carotenoid lutein has been linked to a decrease in the risk of macular degeneration. Isoflavones are known to have estrogenic effects in women. Soy isoflavones, in particular, are said to prevent cancer, reduce cholesterol, reverse osteoporosis, and eliminate menopausal symptoms. Soy isoflavones also have been shown to be protective against heart disease. The catechins in green tea may prevent the cell damage that causes cancer. Catechins also have been found effective in the treatment of atopic dermatitis. Catechins may also reduce the risk of heart disease and stroke.
Other substances also provide nutritional benefits. Creatine is linked to an increase in athletic performance, and may assist in gaining muscle mass. Creatine monohydrate studies show that it boosts size and muscle strength, and increases lean body mass. Phosphate salts are linked to increased energy production and aerobic metabolism. They may also increase the ability of the blood to move oxygen to working muscles and neutralize the production of lactic acid. Dehydroepiandrosterone (DHEA) assists with adrenal deficiency, diabetes and depression, and also is shown to increase energy, improve sleep, and retard signs of aging. It also has been shown to assist in recovery time and fat loss. Coenzyme Q10 (CoQ10) exhibits antioxidant properties, and has been shown to affect the immune system, and is considered as an adjuvant therapy for cancer. Chondroitin sulfate may slow cartilage breakdown and even spur cartilage growth. Dimethylaminoethyl (DMAE) accelerates the production of acetylcholine, necessary for proper brain functioning. Inositol hexaphosphate (IP6) aids in hair growth, as well as production of bone marrow cells. It also assists the liver in fat transfer. Pyruvate, especially from calcium, has been linked with increased exercise performance and enhanced fat loss. Methylsulfonylmethyl (MSM), is a naturally occurring organic sulfur, which (sulfur) is necessary for the creation and regeneration of tissues, as well as collagen synthesis. Sulfur also is a major component in the formation of cartilage and connective tissues
While nutritional supplements are known containing many of the foregoing components, in varying combinations for varying target audiences (i.e., women, athletes, the elderly), presently available nutritional supplements suffer from two deficiencies. First, most nutritional supplements lack a pleasant flavor, so that their daily use (as required for maximum benefit) is compromised by unappealing taste. Second, presently available nutritional supplements generally appear in pill, tablet or capsule form. As such, they must be ingested, and dissolved in the stomach prior to absorption into the bloodstream. This delay between ingestion of the supplement and its absorption into the bloodstream (and the concomitant realization of the beneficial physiologic effect) can be significant, particularly where a supplement is ingested immediately prior to, during, or immediately after exercise. In such a circumstance, the individual requires as immediate an effect as can be realized. Any delay caused by the need to first dissolve the supplement and then transport it into the bloodstream, can prove harmful, or at least can lessen the benefit to be obtained from the supplement.
What is needed is a protein-rich nutritional supplement that includes vitamins, minerals, amino acids or their derivatives and/or analogs, and/or other physiologically beneficial substances, that presents a pleasant taste (improved palatability), and that is in an oral unit dosage form such that the nutritive and dietary benefits of the supplement are able to be quickly absorbed into the bloodstream for maximum effect.
Accordingly, the present invention provides a protein-rich nutritional supplement that includes vitamins, minerals, amino acids or their derivatives and/or analogs, and/or other physiologically beneficial substances, that presents a pleasant taste (improved palatability), and that is in an oral unit dosage form such that the nutritive and dietary benefits of the supplement are able to be quickly absorbed into the bloodstream for maximum effect.